Tether assemblies for medical device delivery systems

ABSTRACT

In some examples, a tether head assembly of a delivery system includes an inner retainer and an outer retainer that defines an aperture comprising a receptacle configured to receive an attachment member of a medical device, a passageway, and a groove. The inner retainer is movable within the groove between a second position in which the passageway is dimensioned to receive the attachment member and a first position in which the passageway is dimensioned to prevent passage of the attachment member. In some examples, a tether handle assembly defines a channel, a force transmitter within the channel, a slidable member partially received within a first end of the channel and a button partially received within a second end of the channel. Distally-directed force applied to the button may cause the force transmitter to apply proximally-directed force to the slidable member, moving the slidable member and an attached pull wire proximally.

This application is a continuation of U.S. application Ser. No.16/847,315, filed Apr. 13, 2020, which claims the benefit of U.S.Provisional Application Ser. No. 62/844,674, filed May 7, 2019, theentire content of which is incorporated herein by reference.

TECHNICAL FIELD

This disclosure relates generally to medical devices, and, moreparticularly, to systems for delivering medical devices.

BACKGROUND

Some types of implantable medical devices (IMDs), such as cardiacpacemakers or implantable cardioverter defibrillators systems, may beused to provide cardiac sensing and therapy for a patient via one ormore electrodes. Some IMDs include an implantable pulse generator thatincludes a housing that encloses electronic components, which may beconfigured to be implanted subcutaneously in the chest of the patient orwithin a chamber of a heart of the patient, as examples. IMDs having apulse generator that is configured to be implanted within a chamber ofthe heart may be referred to as an intracardiac device or a leadlessimplantable medical device. A medical device delivery system including adelivery catheter may be used to deliver an intracardiac devicetransvenously to an implant site within a heart of a patient and releasethe device after the device has been fixed at the implant site. Themedical device delivery system then may be withdrawn from the patient.

SUMMARY

In general, this disclosure is directed to examples of tether assembliesof medical device delivery systems and to techniques using such tetherassemblies. Example tether assemblies may include a distal tether headassembly configured to releasably retain an attachment member of amedical device, e.g., an intracardiac device. Additionally, oralternatively, a tether assembly of a medical device delivery system mayinclude a tether handle assembly configured to retain a proximal end ofa pull wire of the tether assembly. The tether handle assembly includesone or more components (e.g., an actuator) configured to transmit forceto a tether head assembly via the pull wire. The techniques may includeapplying a force to the actuator of the tether handle assembly move thepull wire, thereby enabling removal of the attachment member from thetether head assembly at a treatment site.

The tether head assembly may include an inner retainer and an outerretainer. The outer retainer may define an aperture including areceptacle configured to receive an attachment member of a medicaldevice and a passageway extending from a distal end of the outerretainer proximally to the receptacle. The aperture further may includea groove extending from the distal end of the outer retainer proximallyat least to the receptacle.

The inner retainer may be movable between a first position and a secondposition. When the inner retainer is in the first position, the distalportion of the inner retainer may be partially received in the grooveand extend into the passageway, thereby narrowing the passageway. Thepassageway thus may be dimensioned to prevent passage of the attachmentmember therethrough when the inner retainer is in the first position,such as to prevent passage of the attachment member from the receptaclewhen the attachment member is loaded onto the tether assembly during amedical procedure to deliver the medical device. When the inner retaineris in the second position, the inner retainer does not narrow thepassageway and the passageway thus may be dimensioned to receive theattachment member of the medical device, such as when the medical deviceis being loaded onto the tether assembly or released from the tetherassembly.

The inner retainer may be biased to the first position. When theproximal movement of the pull wire is discontinued and/or when theattachment member has been passed through the passageway and is receivedwithin the receptacle defined by the outer member, anelastically-compressible member of the tether head assembly may expandand apply distally-directed force to the inner retainer, thereby movingthe inner retainer from the second position to the first position.

In other examples, a tether head assembly configured to retain anattachment member of a medical device may include a retainer or othersuch component that is not biased to return to such a first position.The act of loading a medical device onto such other tether assembliesprior to delivery to a heart of a patient may require two people (e.g.,clinicians). A first person may be required to hold the medical devicein position while a second person opens the tether head assembly, suchas by proximally moving a pull wire of the tether assembly to move theinner retainer from a first position in which the tether assembly is“closed” to a second position in which the tether assembly is “open.”The first person then may load the attachment member of the medicaldevice onto the tether head assembly (e.g., by placing the attachmentmember in a receptacle defined by the tether head assembly) and thesecond person may distally move the pull wire to return the tether headassembly to the first position and retain the attachment member withinthe receptacle. Loading a medical device onto a tether assembly usingtwo people may add time and complexity to a medical procedure to deliverthe medical device and/or may increase a possibility of contamination ofthe medical device or other objects within the surgical field.

Example tether head assemblies described herein may enable loading of amedical device onto a tether assembly by one person instead of two. Forexample, bias of the inner retainer to the first position may enable aclinician to hold the tether head assembly in one hand and simply pressthe attachment member into a passageway defined by an outer retainer,thereby moving the inner retainer to the second position as theattachment member moves through the passageway to the receptacle as anelastically-compressible member of the tether head assembly iscompressed. The biasing of an inner retainer to a first positionprovided by the elastically-compressible member may enable the clinicianto simply release his or her hold on the medical device once theattachment member is received within the receptacle allowing the innerretainer to return to the first position.

In this manner, the tether assemblies described herein may reduce thetime and complexity associated with a procedure to deliver the medicaldevice. In some examples, the tether assemblies described herein mayreduce a possibility of contamination of the medical device or otherobjects within the surgical field by reducing the number of people thattouch the medical device and the tether assembly. In some examples, thetether assemblies described herein may provide one or more advantages tothe functionality, reliability, robustness, manufacturability, and costassociated with such tether assemblies.

In some examples, a tether handle assembly as described herein may beused in conjunction with a tether head assembly as described herein anda share pull wire. As an example, a tether assembly may include a tetherhead assembly, a pull wire, and a tether handle assembly attached to aproximal end of the pull wire. The tether handle assembly may include anactuator configured to cause a proximal movement of the pull wire thatenables removal of the attachment member from the tether head assembly.Application of a force to the actuator may cause proximal movement ofthe pull wire, which may enable release of the medical device from thetether head assembly at a treatment site within a patient (e.g., withina heart of the patient). The force applied to the actuator may be adistally-directed force, e.g., a button push. In such examples, one ormore components of the tether handle assembly may be configured totranslate the distally-directed force applied to the actuator to aproximally-directed force applied to the pull wire.

Examples in which a tether handle assembly of a tether assembly of amedical device delivery system is configured to enable release of themedical device from the tether assembly by translating adistally-directed force into a proximally-directed force may provide oneor more advantages. In some examples, a clinician may find applying adistally-directed force (i.e., a pushing force) to a button or slidablemember to release the medical device to be intuitive and/or otherwiseeasier to use than some other tether handle assembly configurations. Insome examples, a clinician may be less likely to accidentally releasethe medical device when using a tether handle assembly configured toenable release of the medical device from the tether assembly viadistally-directed force relative to other actuator configurations.

Any such tether handle assemblies may include one or more componentsconfigured to reduce a possibility of accidental release of the medicaldevice from the tether assembly, such as a lock member or a cover.Additionally, or alternatively, any of the handle assemblies describedherein may enable sensing of electrical signals via an electrical pathincluding the medical device and one or more components of a tetherassembly including the tether handle assembly, which may help enable aclinician to determine positioning of the delivery and medical devicerelative to target tissue, attachment of the medical device to targettissue, and how much force to apply to an actuator of a tether handleassembly to enable release the medical device from the tether assembly.

In some other examples, a tether assembly of a medical device deliverysystem may not be re-usable, such as in other examples in which a tetherassembly includes a string or other such component that is loopedthrough the medical device and then cut after the medical device isfixed at a treatment site. In such other examples, a new tether assemblyand/or medical device delivery system thus may be packaged with eachmedical device. Packaging a medical device delivery system and/or tetherassembly with a medical device may be associated with shelf-lifeconsiderations, such as in examples in which the medical device includesa drug-eluting component that may have an expiration date.

The example tether assemblies described herein may be sterilizable andre-usable, at least in part because the tether assembly can be releasedfrom the medical device without being cut. In some examples, the tetherassembly may be packaged separately from the medical device, such asexamples in which the medical device may include a drug elutingcomponent that has a finite shelf life. In such instances, packaging thetether assembly separately from medical device may mitigate shelf lifeconsiderations with respect to the tether assembly.

Thus, the example tether assemblies described herein may enableone-person loading of a medical device onto a tether assembly, may bemore intuitive for a clinician to operate than some other example tetherassemblies, may reduce a possibility of accidental deployment of amedical device, may enable a clinician to determine placement of themedical device at a treatment site within a patient (e.g., within aheart of the patient), and/or may enable a clinician to monitorelectrical signals from the medical device and/or distal portion of thedelivery system during an implantation procedure.

In one example, a tether assembly of a medical device delivery systemcomprises a pull wire defining a proximal end and a distal end, and atether head assembly. The tether head assembly comprises an innerretainer comprising a proximal portion and a distal portion, wherein theinner retainer is coupled to and extends distally from the distal end ofthe pull wire, and an outer retainer comprising a proximal portiondefining a channel configured to receive the inner retainer and a distalportion defining an aperture. The aperture comprises a receptacleconfigured to receive an attachment member of a medical device, apassageway extending from a distal end defined by the outer retainerproximally to the receptacle, wherein the passageway is narrower thanthe receptacle, and a groove extending from the distal end of the outerretainer proximally at least to the receptacle, wherein the groove has adepth that is less than a thickness of the distal portion of the innerretainer. The inner retainer is movable between a first position whereinthe distal portion of the inner retainer is partially received in thegroove and extends into the passageway, thereby narrowing thepassageway, and a second position wherein the distal portion of theinner retainer is positioned proximal to the passageway.

In another example, a tether assembly of a medical device deliverysystem comprises a tether handle assembly comprising a housing defininga curved channel that defines a first end and a second end, a forcetransmitter received within the curved channel, a slidable memberreceived within the housing such that a portion of the slidable memberis received within the channel at the first end of the channel, and abutton defining a proximal surface and comprising a distal portionreceived within the channel at the second end of the channel, whereinthe button surrounds at least a proximal portion of the slidable member.The tether assembly further comprises a pull wire defining a proximalend and a distal end, wherein the proximal end of the pull wire isreceived within the housing and retained by the slidable member. Thebutton is configured to move from a first position to a second positionin response to application of a distally-directed force to the button,thereby moving the force transmitter toward the first end of the curvedchannel such that the force transmitter applies a proximally-directedforce to the portion of the slidable member received within the channelthat causes the slidable member and the pull wire to move proximally.

In another example, a method for using tether assembly of a medicaldevice delivery system comprises positioning a tether head assembly ofthe tether assembly at a treatment site of a patient with an attachmentmember of a medical device received within a receptacle of the tetherhead assembly, the tether head assembly configured to releasably retainthe attachment member of the medical device. The tether head assemblycomprises an inner retainer comprising a proximal portion and a distalportion, wherein the inner retainer is coupled to and extends distallyfrom the distal end of a pull wire of the medical device deliverysystem, an outer retainer comprising a proximal portion defining achannel configured to receive the inner retainer and a distal portiondefining an aperture. The aperture comprises the receptacle configuredto receive the tether member of the medical device, a passagewayextending from a distal end of the outer retainer proximally to thereceptacle, wherein the passageway is narrower than the receptacle, anda groove extending from the distal end of the outer retainer proximallyat least to the receptacle, wherein the groove has a depth that is lessthan a thickness of the distal portion of the inner retainer.Positioning the tether head assembly comprises positioning the tetherhead assembly with the inner retainer in a first position wherein thedistal portion of the inner retainer is partially received in the grooveand extends into the passageway, thereby narrowing the passageway,wherein the passageway is dimensioned to prevent passage of theattachment member when the inner retainer is in the first position. Themethod further comprises applying a force to an actuator of the tetherassembly to cause a proximal movement of the pull wire, the proximalmovement of the pull wire moving the inner retainer from the firstposition to a second position wherein the distal portion of the innerretainer is positioned proximal to the passageway, wherein thepassageway is dimensioned to receive the attachment member of themedical device when the inner retainer is in the second position,allowing the attachment member of the medical device to pass from thereceptacle through the passageway. The method further comprisesproximally moving the tether assembly with the inner retainer in thesecond position to remove the attachment member of the medical devicefrom the tether head assembly, thereby delivering the medical device tothe treatment site.

In another example, a tether assembly of a medical device deliverysystem comprises a tether handle assembly comprising a housing, a firstslidable member defining a first aperture and received within thehousing, a second slidable member received within the first aperture anddefining a second aperture, and at least one gear received within theaperture defined by the first slidable member and configured tomechanically engage the first slidable member and the second slidablemember. The tether assembly further comprises a pull wire defining aproximal end and a distal end, wherein the proximal end of the pull wireis received within the housing and is retained by the second slidablemember. The first slidable member is configured to move distally inresponse to application of a distally-directed force to the firstslidable member and, when the first slidable member moves distally, andthe at least one gear moves the second slidable member and the pull wireproximally.

In another example, a tether assembly of a medical device deliverysystem comprises a tether handle assembly comprising a housing, aslidable member received within the housing, a plunger coupled to andextending distally from the slidable member. The tether assembly furthercomprises a pull wire defining a proximal end and a distal end, whereinthe proximal end of the pull wire is received within the housing and isretained by the slidable member. The plunger is configured to move froma first position to a second position in response to application of aproximally-directed force to the plunger that causes the slidable memberand the pull wire to move proximally.

In another example, a method for using a tether assembly of a medicaldevice delivery system comprises positioning a tether head assembly ofthe tether assembly at a treatment site of a patient with an attachmentmember of a medical device received within a receptacle of the tetherhead assembly, the tether head assembly configured to releasably retainthe attachment member of the medical device. The method furthercomprises applying a force in a distal direction to an actuator of atether handle assembly of the tether assembly to cause a proximalmovement of the pull wire, the proximal movement of the pull wireopening the tether head assembly, and proximally moving the tetherassembly with the tether head assembly open to remove the attachmentmember of the medical device from the tether head assembly, therebydelivering the medical device to the treatment site.

This summary is intended to provide an overview of the subject matterdescribed in this disclosure. It is not intended to provide an exclusiveor exhaustive explanation of the apparatus and methods described indetail within the accompanying drawings and description below. Furtherdetails of one or more examples are set forth in the accompanyingdrawings and the description below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a conceptual drawing illustrating portions of patient anatomyincluding potential implant sites for an implantable medical device(IMD);

FIG. 2 is a plan drawing illustrating an example medical device deliverysystem for delivering an IMD to a location within a heart;

FIG. 3 is a conceptual drawing illustrating, in conjunction with tissueof a heart, a distal portion of the example medical device deliverysystem of FIG. 2 carrying an example IMD.

FIG. 4A is a plan view of a distal portion of an example tether assemblyincluding a tether head assembly and pull wire, where a distal portionof the tether head assembly is outlined;

FIG. 4B is an exploded plan view of the distal portion of the exampletether assembly of FIG. 4A, where a distal portion of an inner retainerof the tether head assembly is outlined;

FIG. 4C is a plan view of the distal portion of the inner retaineroutlined in FIG. 4B;

FIG. 4D is a plan view of the distal portion of the tether head assemblyoutlined in FIG. 4A;

FIG. 5A is a side view of the distal portion of the example tetherassembly of FIG. 4A-4D in conjunction with a side view of the IMD ofFIG. 3, where the tether head assembly and the IMD are not connected;

FIG. 5B is a cross-sectional view of the highlighted portion of FIG. 5Aincluding the tether head assembly and a proximal portion of the IMD,where the cross-section is taken along line A—A of FIG. 5A in a planeparallel to a longitudinal axis of the tether head assembly alongitudinal axis of the IMD;

FIG. 5C is a cross-sectional view of the highlighted portion of FIG. 5Aincluding the tether head assembly and the proximal portion of the IMDwith the inner retainer in the second position and the attachment memberof the IMD within the receptacle defined by the outer retainer;

FIG. 5D is a cross-sectional view of the highlighted portion of FIG. 5Aincluding the tether head assembly and the proximal portion of the IMDwith the attachment member of the IMD held within the receptacle definedby the outer retainer by inner retainer in the first position;

FIG. 6A is an exploded view of a distal portion of another exampletether assembly including a tether head assembly and a pull wire, wherea distal portion of an inner retainer of the tether head assembly ofFIG. 6A is outlined;

FIG. 6B is a plan view of the distal portion of the inner retaineroutlined in FIG. 6A;

FIG. 6C is a plan view of the distal portion of the inner retainer ofFIG. 6B received within an outer retainer of the tether head assembly ofFIG. 6A;

FIG. 6D is a cross-sectional view of the example tether head assembly ofFIG. 6A and a proximal portion of the IMD of FIG. 3, where thecross-section is taken along a plane parallel to a longitudinal axis ofthe tether head assembly and a longitudinal axis of the IMD;

FIG. 7 is a functional block diagram illustrating an exampleconfiguration of an IMD;

FIG. 8 is a flow diagram illustrating an example technique for using theexample tether assemblies of FIGS. 4A-6D;

FIG. 9A is a plan view of an example tether handle assembly of aproximal portion of another example tether assembly;

FIG. 9B is an exploded plan view of the tether handle assembly of FIG.9A;

FIGS. 10A-10D are side views of the tether handle assembly of FIGS. 9Aand 9B with a portion of a housing of the tether handle assemblyremoved, illustrating movement of a force transmitter, a slidablemember, and a pull wire of the example tether assembly of FIGS. 9A and9B in response to movement of a button of the tether handle assemblyfrom a first position to a second position;

FIGS. 11A-11J are plan views of components of the tether handle assemblyof the example tether assembly of FIGS. 9A and 9B, illustrating anexample technique for assembling the tether handle assembly;

FIGS. 12A-12E are plan views of another example tether handle assemblyof a tether assembly, the tether handle assembly including a cover for abutton;

FIGS. 13A and 13B are plan views of a proximal end of another exampletether assembly including another example tether handle assembly;

FIG. 13C is an exploded plan view of the example tether handle assemblyof FIGS. 13A and 13B;

FIGS. 13D and 13E are plan views of the example tether handle assemblyof FIGS. 13A-13C, with a portion of the housing removed, illustratingmovement of a plurality of gears, a second slidable member, and a pullwire of the example tether handle assembly in response to movement of afirst slidable member of the tether handle assembly from a firstposition to a second position;

FIG. 14 is a flow diagram illustrating an example technique for using amedical device delivery system comprising a tether assembly thatincludes a tether handle assembly as described with respect to FIGS.9A-13E and a tether head assembly as described with respect to FIGS.4A-6D;

FIG. 15A is a side view of another example tether assembly includinganother example tether handle assembly;

FIG. 15B is an exploded plan view of the tether handle assembly of FIG.15A;

FIGS. 15C-15E are perspective views of the tether handle assembly ofFIGS. 15A and 15B with a portion of the housing removed, illustratingdifferent positions of a lock member and a plunger of the tether handleassembly;

FIG. 16A is an exploded plan view of another example tether handleassembly;

FIG. 16B is a cross-section view of the example tether handle assemblyof FIG. 14A;

FIG. 17A is an exploded plan view of another example tether handleassembly;

FIG. 17B is a cross-section view of the example tether handle assemblyof FIG. 17A;

and

FIG. 17C is a plan view of the collar portion of the plunger of theexample tether handle assembly of FIG. 17A.

DETAILED DESCRIPTION

In general, this disclosure describes example medical device deliverysystems. Such medical device delivery systems may include a tetherassembly comprising a tether head assembly, and tether handle assembly,and a pull wire. The tether head assembly is attached to the pull wireand configured to releasably retain an attachment member of a medicaldevice (e.g., an intracardiac device). In some examples, a tether handleassembly is configured to retain the pull wire attached to the tetherhead assembly. The tether handle assembly may include an actuatorconfigured to transmit force to the tether head assembly via the pullwire and enable removal of the attachment member of a medical devicefrom the tether head assembly at a treatment site within a patient.Although the example tether assemblies are generally described herein asbeing configured for delivering an implantable medical device (IMD), itshould be understood that any of the example tether assemblies describedherein alternatively may be configured for delivering other types ofmedical devices.

FIG. 1 is a conceptual drawing illustrating portions of patient anatomyincluding potential implant sites for an IMD. For example, an IMD may beimplanted on or within heart 1 of a patient, such as within an appendage2 of a right atrium (RA), within a coronary vein (CV) via a coronarysinus ostium (CSOS), or in proximity to an apex 3 of a right ventricle(RV). In other examples, an IMD may be implanted on other portions ofheart 1 or implanted in locations other than heart 1, such as anysuitable implant site in a body of the patient.

FIG. 2 is a plan drawing illustrating an example medical device deliverysystem 4 for delivering an IMD (not shown in FIG. 1) to a locationwithin heart 1. Although described herein in the context of deliveringan IMD into the vasculature, e.g., heart 1, the devices, systems, andtechniques of this disclosure may be used to deliver an IMD to anyanatomical location.

System 4 includes an introducer 5, a delivery catheter 6, and a tetherassembly 12. Introducer 5 is an elongated member defining an interiorlumen. Introducer 5 is configured to be inserted, such as by aphysician, into a vasculature of a patient to provide a rigid channel,via the interior lumen, through which to insert a medical instrument, adevice, or other therapy.

Delivery catheter 6 is configured to be inserted through the lumen ofintroducer 5 to deliver an IMD within the vasculature. Delivery catheter6 includes an elongated shaft 9, a handle 7, and a device cup 8. Handle7 is disposed at a proximal end of shaft 9, and may include one or moreelements (such as buttons, switches, etc.) configured to control themotion of the distal end of shaft 9 and release of the IMD from devicecup 8, as examples.

Device cup 8 is disposed at a distal end of shaft 9. Device cup 8includes a hollow cylindrical body configured to house and support anIMD (e.g., IMD 10 described with respect to FIG. 3) while the IMD isbeing implanted within a vasculature of a patient. For example, aphysician may insert the distal end of delivery catheter 6, includingdevice cup 8, through the lumen of introducer 5, which is disposedwithin a vasculature of a patient. Once device cup 8 has extendedthrough the distal end of introducer 5 and reached an implant sitewithin the patient, the physician may release the IMD from a distalopening 11 of device cup 8 and withdraw delivery catheter 6 proximallythrough introducer 5.

Tether assembly 12 extends through a lumen defined delivery catheter,e.g., including handle 7 and shaft 9. Tether assembly 12 an elongatebody 20, a tether handle assembly 13 at a proximal end of elongate body20, and a tether head assembly 18 (FIG. 3) at a distal end of elongatebody 20. A pull wire (not shown in FIG. 2) may extend from tether handleassembly 13 to tether head assembly 18 through a lumen defined byelongate body 20.

Tether assembly 12 may be of sufficient length that a clinician maymanipulate tether handle assembly 13 to advance tether head assembly 18out of distal opening 11 of cup 8. In some examples, with tether headassembly 18 outside of cup 8, a clinician may attach an IMD to tetherhead assembly 18 as described herein. The clinician may then load theIMD into cup 8 via distal opening 11, and advance delivery catheter 6,with tether assembly 12 and the IMD therein, through introducer 5 andinto the vasculature.

FIG. 3 is a conceptual drawing illustrating, in conjunction with tissue15 of heart 1, a distal portion of medical device delivery system 4carrying an example IMD 10. IMD 10 may be a pacemaker device having ahousing 80 that contains electronic components suitable for performing avariety of pacing functions. However, IMDs configured to deliver othertypes of electrical therapy to a patient may be adapted for use withdelivery system 4. IMD 10 may include an attachment member 14 at aproximal end thereof and fixation members 16 at a distal end thereof.Tether head assembly 18 may be configured to receive and retainattachment member 14, as further discussed below with respect to FIGS.4A-5D.

In some examples, IMD 10 may include a hermetically sealed housing 80defining a proximal end 82 and a distal end 84. Housing 80 may contain apulse generator and an associated power supply (not shown) and anelectrode 86, which may be positioned at distal end 84 of housing 80 andwhich may be electrically coupled to the pulse generator of IMD 10 via ahermetically sealed feedthrough assembly (not shown). Housing 80 may beformed from any suitable biocompatible and biostable metal. For example,housing 80 may be formed from titanium and may be overlaid with aninsulative layer (e.g., a medical grade polyurethane, parylene, orsilicone). In some examples, IMD 10 may include a housing electrode 88,which may be formed by removing a portion of the insulative layer toexpose a metallic surface defined by housing 80. In such examples,housing electrode 88 of IMD 10 may function in conjunction withelectrode 86, such as for bipolar pacing and sensing.

FIG. 3 illustrates the distal end cup 8 of delivery catheter 6 pressedagainst tissue 15 at the implant site of heart 1. When a clinician issatisfied with the positioning of cup 8 with respect to tissue 15, e.g.,that a longitudinal axis of cup 8 is generally orthogonal to a planedefined by tissue 15, and that cup 8 pressed sufficiently against/intotissue 15 such that fixation members 16 of IMD 10 will deploy into thetissue, the clinician may advance IMD 10 towards distal opening usingtether assembly 12, e.g., by using tether assembly handle 13 to advancetether assembly 12 distally relative to delivery catheter 6. Fixationmembers 16 may be configured to embed into tissue 15, and in some casespull IMD 10 through distal opening 11 of cup, when advanced through thedistal opening. While IMD 10 is shown having fixation members 16 thatincludes a plurality of tine structures, it should be understood thatIMD 10 may include any other suitable fixation structure or structures,such as a screw-shaped fixation structure (helix) that may be rotatedinto tissue at an implant site.

IMD 10 may, for a time, remain attached to tether assembly 12 byattachment member 14 and tether head assembly 18 while fixed to tissue15 by fixation members 16. Thus, the clinician may be able to test thefixation of IMD 10 at the implant site and/or remove IMD 10 from theimplant site and back into cup 8 for repositioning at a more suitablesite, if necessary. Once satisfied with the implantation of IMD 10, theclinician can separate tether head assembly 18 from attachment mechanism14 and move tether assembly 12 proximally, as described in greaterdetail below, and then withdraw delivery catheter 6 and tether assembly12 from the patient through introducer 5.

For example, tether assembly 12 may include a pull wire (not shown) asdiscussed in further detail with respect to FIGS. 4A-5D. Such a pullwire may be attached at a distal end thereof to tether head assembly 18and attached at a proximal end thereof to tether handle assembly 13,examples of which are discussed below with respect to FIGS. 9A-17C. Theclinician may apply force to an actuator of tether handle assembly tocause tether head assembly 18 to move from a closed position, in whichattachment member 14 is retained within tether head assembly 18, to anopen position in which attachment member 14 may be released from tetherhead assembly 18. With tether head assembly 18 in the open position, theclinician may proximally move tether assembly 12 to remove attachmentmember 14 from tether head assembly 18, leaving IMD 10 fixed at thetreatment site.

A clinician may secure attachment member 14 of IMD 10 to tether headassembly 18 by pressing attachment member 14 into a passageway definedby tether head assembly 18, thereby opening tether head assembly 18 froma first (e.g., closed) position to a second (e.g., open) position andadvancing attachment member 14 through the passageway until tethermember 14 is received within a receptacle defined by tether headassembly 18, as further discussed below with respect to FIGS. 4A-5D.This may be accomplished by one clinician instead of the two cliniciansthat may be required to secure an attachment member of an IMD to atether assembly in some other example medical device delivery systems.Thus, tether assembly 12 may reduce the time and complexity associatedwith a procedure to deliver IMD 10. In some examples, tether headassembly 18 may reduce a possibility of contamination of the medicaldevice or other objects within the surgical field, relative to suchother tether assemblies, by reducing the number of people that touch IMD10 and tether head assembly 18.

As described herein, a clinician may secure attachment member 14 of IMD10 to tether head assembly 18 at the time of a medical procedure todeliver IMD 10. In addition, the clinician may release IMD 10 fromtether head assembly 18 without cutting a portion of tether assembly 12.In some examples, tether head assembly 18 thus may reduce or eliminatedrawbacks that may be associated with other types of tether mechanisms,such as tension associated with pulling on such other tether mechanisms(e.g., a loop of string or similar material), potential twisting orbinding of such other tether mechanisms, or the like. The re-usabilityof tether assembly 12 may mitigate shelf life considerations withrespect to tether assembly 12, delivery system 4, and IMD 10, such as inexamples in which IMD 10 includes a drug eluting component with a finiteshelf life. For example, tether assembly 12 and/or delivery system 4 maynot necessarily be associated with a finite shelf life when packagedseparately from IMD 10.

During delivery of IMD 10 to the treatment site via delivery system 4, aclinician may advance cup 8 into contact with tissue 15 of heart 1 priorto engaging fixation members 16 with tissue 15 of heart 1. The clinicianthen may determine whether cup 8 and IMD 10 are properly positioned atthe implant site prior to engaging fixation members 16 with the tissue15 of heart 1. In some examples, the clinician may determine whether cup8 and IMD 10 is properly positioned relative to heart 2 based on animpedance or other electrical signal sensed via an electrical pathincluding IMD 10 (e.g., housing 80 or an electrode 88), attachmentmember 14, and one or more components of tether assembly 12 (e.g., oneor more components of tether head assembly 18). In addition to the IMD,another electrode of the electrical path may be a reference electrodeattached to the patient, or inside the patient but located outside ofcup 8. In some examples, relatively higher impedance may be indicativeof cup 8 being positioned flush against, and with adequate depth in,tissue 15 of heart 1, which may be desirable for proper fixation. Afterdeployment of fixation members 16 and IMD 10 from cup 8, with IMD 10fixed to tissue 15, an impedance or electrical signal may also indicatethe quality of the fixation of IMD 10 to tissue, e.g., based onvariations of the impedance during a “tug test” in which a clinicianpulls on tether assembly 12 while attached to IMD 10 and while IMD 10 isfixed to tissue 15. Some examples may employ any of the techniques fortesting the spatial relationship of a cup and/or IMD to tissue, and fortesting fixation of an IMD to tissue, described in U.S. patentapplication Ser. No. 16/146,391, filed Sep. 28, 2018 by Medtronic, Inc.,and titled “Impedance-Based Verification for Delivery of ImplantableMedical Devices,” which is incorporated herein by reference in itsentirety.

FIGS. 4A-6D illustrate examples of distal portions of tether assembliesincluding example tether head assemblies. It should be noted thatalthough FIGS. 4A-6D may be described with respect to IMD 10, deliverysystems may be used to deliver other suitably configured medicaldevices.

FIG. 4A is a plan view of a distal portion of a tether assembly 12 withthe components of tether assembly 12 in an assembled configuration,where a distal portion of a tether head assembly 18 is outlined. FIG. 4Bis an exploded plan view of the distal portion tether assembly 12, wherea distal portion of an inner retainer 36 of tether head assembly 18 isoutlined. FIG. 4C is a plan view of the distal portion of the innerretainer 36 outlined in FIG. 4B. FIG. 4D is a plan view of the distalportion of the tether head assembly 18 outlined in FIG. 4A.

As illustrated in FIG. 4A, elongate body 20 may include a shaft defininga lumen (not shown) in which a portion of a pull wire 34 is received.Tether head assembly 18 may include inner retainer 36, an outer retainer38, and a sheath 40. Components of tether assembly 12 may be separatelyformed of any suitable material. In some examples, one or more of pullwire 34, inner retainer 36, outer retainer 38, sheath 40, and/or one ormore layers of elongate body 20 may be formed of an electricallyconductive material, which may help enable testing of placement of IMD10 during a procedure to deliver IMD 10, as discussed above with respectto FIG. 3. One or more components of tether assembly 12 may bemanufactured via a technique such as metal injection molding or anyother suitable technique.

Inner retainer 36 may be coupled to pull wire 34 and extends distally offrom a distal end (not shown) of pull wire 34. A distal portion 56 ofouter retainer 38 defines an aperture 42 that, as illustrated in FIG. 4Bincludes a receptacle 44 dimensioned to receive attachment member 14 ofIMD 10 and a passageway 46. Passageway 46 may extend from a distal end48 defined by outer retainer 38 proximally to receptacle 44 and may benarrower than receptacle 44.

A proximal portion 54 of outer retainer 38 may define a channel (notshown) configured to receive inner retainer 36. Inner retainer 36 may bereceived within outer retainer 38 in a first position in which a distalportion 52 of inner retainer 36 extends into passageway 46, as shown inFIGS. 4A and 4D. When inner retainer 36 is in the first position,passageway 46 may be dimensioned to prevent passage of attachment member14 of IMD 10 (e.g., is too narrow to allow passage of attachment member14).

Proximal movement of pull wire 34 may cause movement of inner retainer36 from the first position to a second position in which inner retainer36 does not extend into passageway 46. Additionally, or alternatively,an application of force to inner retainer 36, e.g., a distal end ofinner retainer 36, by attachment member 14 of IMD 10 may cause innerretainer 36 to move from the first position to the second position. Withinner retainer 36 in the second position, passageway 46 may bedimensioned to receive tether member 14. Inner retainer 36 and outerretainer 38 may be received within sheath 40, and more particularly acavity 64 defined by sheath 40, which may help retain inner retainer 36within outer retainer 38 and couple outer retainer 38 to elongate body20.

In some examples, the configuration of inner retainer 36 and outerretainer 38 may substantially isolate the function of retainingattachment member 14 of IMD 10 to tether head assembly 18, rather thanpull wire 34 or another element that extends to a handle assembly oftether assembly 12. For example, as tether assembly 12 is navigatedthrough curved portions of patient vasculature, the path lengths of pullwire 34 and/or shaft 20 may change. In some other example medical devicedelivery systems in which the tether assembly relies on a pull wire toretain an attachment member within a tether head assembly, such changesin path lengths of a pull wire and/or shaft may cause a loss of contactbetween the pull wire and the attachment member, thereby adverselyaffecting retention of the attachment member during delivery.

In the example of tether assembly 12 and other tether assembliesdescribed herein, changes in path length of pull wire 34 and/or shaft 20of tether assembly 12 may not cause substantial proximal or distalmovement of inner retainer 36. For example, sheath 40 and/or anelastically-compressible member 60 may help reduce or prevent proximalmovement of inner retainer 36 as path lengths of pull wire 34 and/orshaft 20 change during navigation of curved vasculature. In this manner,the substantial isolation of the IMD retention function within tetherhead assembly 18 may help maintain retention of attachment member 14 astether assembly 12 is navigated through curved vasculature.

In FIG. 4B a distal portion of inner retainer 36 is outlined, and thatportion of inner retainer 36 is illustrated in greater detail in FIG.4C. As shown in FIG. 4B, inner retainer 36 may include a proximalportion 50 and a distal portion 52. Outer retainer 38 may include aproximal portion 54 and a distal portion 56. Proximal portion 54 ofouter retainer 38 may define a channel (not shown) dimensioned toreceive proximal portion 50 of inner retainer 36. Distal portion 56 ofouter retainer 38 may define aperture 42. In some examples, aperture 42may further include a groove 58 extending from distal end 48 of outerretainer 38 proximally at least to receptacle 44. Groove 58 may bepartially defined by distal portion 56 of outer retainer 38 and may havea depth that is less than a thickness of distal portion 52 of innerretainer 36. A value by which the thickness of distal portion 52 ofinner retainer 36 exceeds the depth of groove 58 may correspond to adistance that inner retainer 36 extends, e.g., transverse to alongitudinal axis defined by inner retainer 36, into passageway 46.

FIG. 4B further illustrates elastically-compressible member 60, which isreceivable within cavity 64 defined by sheath 40 proximal of, e.g., inan abutting relationship with, inner retainer 36.Elastically-compressible member 60 may be formed of a suitablyelastically-compressible material, such as a polymer.Elastically-compressible member 60 may define a lumen 62 through which adistal portion of pull wire 34 may extend and be attached to moredistally located inner retainer 36. In some examples,elastically-compressible member 60 may be configured to bias innerretainer 36 to the first position. For example, elastically-compressiblemember 60 may define a longitudinal axis, which may correspond to alongitudinal axis of tether assembly 18. Axial expansion ofelastically-compressible member 60 relative to the longitudinal axiscauses elastically-compressible member 60 to apply a distally-directedforce to inner retainer 36, thereby causing inner retainer 36 to movefrom the second position to the first position.

In this manner, elastically-compressible member 60 may function as aspring that biases inner retainer 36 to the first position. Biasing ofinner retainer 36 to the first position may provide one or moreadvantages, such as enabling a clinician to load IMD 10 onto tether headassembly 18 without necessarily requiring the assistance of anotherclinician. Elastically-compressible member 60 may be received withinsheath 40 when tether assembly 12 is in an assembled configuration,e.g., shown in FIG. 4A. In this manner, sheath 40 may provide a backstopagainst which elastically-compressible member 60 may be compressedduring movement of inner retainer 36 from the first position to thesecond position.

The form of elastically-compressible member 60 illustrated in FIG. 4B isan example. In other examples, other forms of elastically-compressiblemember may be used to provide the functionality described with respectto elastically-compressible member 60 herein. For example, anelastically-compressible member may take the form of a coil or spring.Additionally, elastically-compressible members may be formed from avariety of materials, such as polymers or metals.

FIG. 4C is a plan view of distal portion 52 of inner retainer 36outlined in FIG. 4B. As illustrated in FIG. 4C, distal portion 52 ofinner retainer 36 may define a first portion 70, a second portion 72,and a third portion 74. First portion 70 may include the distal end ofinner retainer 36 and may have a first thickness. Second portion 72 maybe proximal to first portion 70 and may have a second thickness that isgreater than the first thickness of first portion 70. Third portion 74may extend between first portion 70 and second portion 72 and may taperin thickness from the first thickness of first portion 70 to the secondthickness of second portion 72. In this manner, the tapered thickness ofthird portion 74 may define a “ramp” surface from proximal portion 70toward second portion 72 and receptacle 44.

When attachment member 14 of IMD 10 is received in receptacle 44 (e.g.,when inner retainer 36 is in the first position), the ramp surfacedefined by third portion 74 may help ensure substantially constantphysical contact between attachment member 14 and at least third portion74 of inner retainer 36. The physical contact between attachment member14 and inner retainer 36 enabled by third portion 74 is illustrated inFIG. 5D and further discussed with respect thereto.

In some examples, inner retainer 36 and attachment member 14 may beelectrically conductive. In such examples, ensuring substantiallyconstant physical contact between attachment member 14 and innerretainer 36 during a method of delivering IMD 10 may enable use as anelectrical connection and/or may help reduce electrical noise thatotherwise may be caused by intermittent contact between attachmentmember 14 and inner retainer 36. A reduction in such electrical noisemay help enable determination of whether IMD 10 is properly positionedand/or affixed relative to tissue of heart 1 during electrical testingof IMD 10 prior to release of IMD 10 from tether head assembly 18 at theimplant site.

FIG. 4D illustrates a manner in which distal portion 52 of innerretainer 36 may be received within groove 58 defined by distal portion56 of outer retainer 38 when inner retainer 36 is in the first position.In some examples, groove 58 may extend proximally from distal end 48 ofouter retainer 38 toward receptacle 44. In some examples, groove 58 mayextend proximally past receptacle 44 toward proximal portion 54 of outerretainer 38. In any such examples, groove 58 may help provide support todistal portion 52 of inner retainer 36, such as by reducing apossibility of distal portion 52 being bent sideways during loading ofattachment member 14 of IMD 10 into receptable 44, or other use oftether assembly 12. In this manner, groove 58 may help maintain themechanical integrity and functionality of tether assembly 12 during oneor more uses, thereby contributing to the durability of tether assembly12.

FIG. 5A is a side view of the distal portion of tether assembly 12,including tether head assembly 18, in conjunction with a side view ofIMD 10, where tether head assembly 18 and IMD 10 are not connected. FIG.5B is a cross-sectional view of the portion of tether head assembly 18and of the proximal portion of IMD 10 highlighted in FIG. 5A, where thecross-section is taken along line A—A of FIG. 5A in a plane parallel toa longitudinal axis of tether head assembly 18 and a longitudinal axisof the IMD 10. FIG. 5C is a cross-sectional view of the highlightedportion of FIG. 5A including the distal portion of tether head assembly18 and the proximal portion of IMD 10, but with inner retainer 36 in thesecond position and attachment member 14 within receptacle 44 defined bythe outer retainer 38. FIG. 5D is a cross-sectional view of thehighlighted portion of FIG. 5A including the distal portion of tetherhead assembly 18 and the proximal portion of IMD 10, but with attachmentmember 14 held within receptacle 44 defined by outer retainer 38 byinner retainer 36 being in the first position.

FIGS. 5A and 5B illustrate IMD 10 detached from tether assembly 12, asmay be the case prior to loading IMD 10 onto tether assembly 12 or afterIMD 10 has been implanted at a desired tissue site. In particular, inFIGS. 5A and 5B, attachment member 14 of IMD 10 is not received withintether head assembly 18 of tether assembly 12.

FIG. 5B illustrates sheath 40 of tether head assembly 18 attached to thedistal end of elongate member 20 of tether assembly 12. Pull wire 34extends through a lumen defined by elongate member 20 and into cavity 64(FIG. 4B) defined by sheath 40. Elastically-compressible member 60,proximal portion 50 of inner retainer 36, and proximal portion 54 ofouter retainer 38 are disposed within cavity 64, with a distal portion66 of elastically-compressible member 60 and proximal portion 50 ofinner retainer 36 received within a channel 68 (FIG. 5C) defined byproximal portion 54 of outer retainer 38. Pull wire 34 extends throughlumen 62 defined by elastically-compressible member 60, and is connectedto inner retainer 36, e.g., fixedly received within proximal portion 50of inner retainer 36. Various components of delivery system 12 andtether assembly 18 may be connected by any of a variety of techniques,such as welding, crimping, threading, reflowing, bonding, adhesives, orfriction fits.

Distal portion 52 of inner retainer 36 extends into distal portion 56 ofouter retainer 38 to contribute to the definition of receptacle 44. Inthe illustrated first position of inner retainer 36, distal portion 52of inner retainer 36 also extends into passageway 46 to reduce the sizeof the passageway such that a thickness or depth of the passageway issmaller than a thickness of attachment member 14 of IMD 10. In theillustrated first position of inner retainer 36, distal portion 52 ofinner retainer 36 may be disposed within groove 58 defined by distalportion 56 of outer retainer 38, as described herein. In the illustratedfirst position of inner retainer 36, elastically-compressible member 60may be in a relaxed, or lower kinetic energy state.

As illustrated in FIG. 5B, attachment member 14 of IMD 10 may beincluded as part of a structure that provides a variety of featuressupporting a variety of functions related to delivery and retrieval ofIMD 10. In the illustrated example, attachment member 14 is formedwithin, and joined to housing 80 of IMD 10, by a shroud structure 90. Inthe illustrated example, attachment member 14 comprises a pin (alsoreferred to as a strut) that is welded or otherwise fixedly attached toshroud structure 90. Attachment member 14 provides an elongate holdingsurface that is spaced apart from housing proximal end 82 of housing 80and that extends along a length substantially orthogonal to alongitudinal axis of IMD 10.

Shroud structure 90 may define a cavity with an opening and attachmentmember 14 may span and be exposed at the opening. Attachment member 14may be welded at either end to opposing sides of shroud structure 90.Distal portion 56 of outer retainer 38 may be configured to enter orotherwise interact with shroud structure 90 when attachment member 14 isreceived within passageway 46 and receptacle 44. The configuration ofshroud structure 90 and distal portion 56 of outer retainer 38 mayselectively inhibit or allow relative motion of IMD 10 and tetherassembly in a variety of directions. It should be understood that shroudstructure 90 and attachment member 14 are provided for example only, andthat a variety of other attachment members may be configured to beattached to tether assemblies as described herein.

FIG. 5C illustrates inner retainer 36 in the second position andattachment member 14 within receptacle 44 defined by the outer retainer38. Inner retainer 36 may be moved to the second position by aproximally directed force. The proximally directed force may be providedby a pulling force from pull wire 34 or a pushing force on distal end 65of inner retainer 36 as attachment member 14 is pushed throughpassageway 46 and into receptacle 44. As illustrated in FIG. 5C,movement of inner retainer 36 to the second position has compressedelastically-compressible member 60, e.g., such that distal portion 66 isno longer located within channel 68 defined by proximal portion 54 ofexternal retainer 38.

When in this compressed state, elastically-compressible member 60 mayhave higher kinetic energy to be released by expanding in the directionof its longitudinal axis to the expanded or relaxed state illustrated inFIGS. 5B and 5D, thereby moving inner retainer 36 from the secondposition to the first position illustrated in FIGS. 5B and 5D. FIG. 5Dillustrates attachment member 14 held within receptacle 44 defined byouter retainer 38 by inner retainer 36 being in the first position.Receptacle 44 is configured, e.g., sized and shaped, to retainattachment member 14 while allowing distal portion 52 of inner retainer36 to move past the attachment member, e.g., through passageway 46. Asillustrated in FIG. 5D, at least third portion 74 of distal portion 52of inner retainer 36 may contact attachment member 14 of IMD 10 when theattachment member is positioned within receptable 44, e.g., when innerretainer 36 is in the first position. As described herein, third portion74 may secure attachment member 14 within receptacle 44 and help ensuresubstantially constant physical contact between attachment member 14 andat least third portion 74 of inner retainer 36. The physical contactbetween attachment member 14 and inner retainer 36 enabled by thirdportion 74 may provide substantially constant electrical contact forconduction of electrical signals, e.g., for impedance monitoring, fromIMD 10 to a proximal portion of tether assembly 12.

FIG. 6A is an exploded view of a distal portion of another exampletether assembly 112 including another example tether assembly 118 and apull wire 134, where a distal portion 152 of an inner retainer 136 oftether head assembly 118 is outlined. FIG. 6B is a plan view of theoutlined portion of FIG. 6A, including distal portion 152 of innerretainer 136 in conjunction with a distal portion 176 of pull wire 134.FIG. 6C is a plan view of distal portion 152 of inner retainer 136received within an outer retainer 38 of tether head assembly 118. FIG.6D is a cross-sectional view of tether head assembly 118 and a proximalportion of IMD 10, where the cross-section is taken along a planeparallel to a longitudinal axis of the tether head assembly and alongitudinal axis of the IMD. Except as noted herein, tether assembly112 and tether head assembly 118 may be substantially similar to tetherassembly 12 and tether head assembly 18 described above with respect toFIGS. 4A-5D. For example, components of tether assembly 112 and tetherhead assembly 118 having the same reference numbers as components intether assembly 12 and tether head assembly 18 may be configured andfunction as described with respect to FIGS. 4A-5D.

In the example of FIGS. 6A-6D, inner retainer 136 differs from innerretainer 36 described above with respect to FIGS. 4A-5D. Like innerretainer 36, inner retainer 136 includes a proximal portion 150 receivedin a channel defined by a proximal portion 54 of outer retainer 38.Inner retainer 136 also includes a distal portion 152 that is supportedby groove 58 defined by However, distal portion 152 of inner retainer136 does not include portions having different thickness, e.g., likeportions 70, 72, and 74 of distal portion 52 of inner retainer 36. Insome examples, distal portion 152 defines a substantially constantthickness along its length. Attachment member 14 may apply force todistal end 65 of inner retainer 136 and move inner retainer 136 to thesecond position as elastically-compressible member 60 is compressed,thereby allowing attachment member 14 to pass through passageway 46 andinto receptacle 44. Inner retainer 136 may return to the first position,e.g., in response to longitudinal expansion of elastically-compressiblemember 60, to retain attachment member 14 in receptacle 44, as shown inFIG. 6D. However, distal portion 152 may not include a ramped orelevated surface to contact attachment member 14, e.g., as provided byportion 74 of distal portion 52 of inner retainer 36. distal portion 56of outer retainer 38. Like inner retainer 36, distal portion 152 ofinner retainer 136 extends into aperture 42 to reduce a size ofpassageway 46 when inner retainer 136 is in the first position andelastically-compressible member 60 is in its relaxed stat.

FIGS. 6A-6D also illustrate a different coupling of pull wire 134 andinner retainer 136 then the coupling of pull wire 34 to inner retainer36. In particular, pull wire 134 includes a bent distal portion 176.Proximal portion 150 of inner retainer 136 defines a notch or othercorresponding feature (FIG. 6D) configured to receive bent distalportion 176. When pull wire 134 is actuated, distal portion 176 may bearagainst proximal portion 150 to move inner retainer 136 from the firstposition to the second position. In some examples, the coupling of pullwire 134 and inner retainer 136 illustrated in FIGS. 6A-6D may allowsome relative movement between these structures, e.g., in response tobending and changes in length of pull wire 134 during an implantprocedure.

FIG. 7 is a functional block diagram illustrating an exampleconfiguration of IMD 10. As shown in FIG. 7, IMD 10 includes processingcircuitry 220, sensing circuitry 222, therapy delivery circuitry 224,sensors 226, communication circuitry 228, and memory 230. In someexamples, memory 230 includes computer-readable instructions that, whenexecuted by processing circuitry 220, cause IMD 10 and processingcircuitry 220 to perform various functions attributed to IMD 10 andprocessing circuitry 220 herein. Memory 230 may include any volatile,non-volatile, magnetic, optical, or electrical media, such as a randomaccess memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM),electrically-erasable programmable ROM (EEPROM), flash memory, or anyother digital media.

Processing circuitry 220 may include fixed function circuitry and/orprogrammable processing circuitry. Processing circuitry 220 may includeany one or more of a microprocessor, a controller, a digital signalprocessor (DSP), an application specific integrated circuit (ASIC), afield-programmable gate array (FPGA), or equivalent discrete or analoglogic circuitry. In some examples, processing circuitry 220 may includemultiple components, such as any combination of one or moremicroprocessors, one or more controllers, one or more DSPs, one or moreASICs, or one or more FPGAs, as well as other discrete or integratedlogic circuitry. The functions attributed to processing circuitry 220herein may be embodied as software, firmware, hardware or anycombination thereof.

In some examples, processing circuitry 220 may receive (e.g., from anexternal device), via communication circuitry 228, a respective valuefor each of a plurality of cardiac sensing parameters, cardiac therapyparameters (e.g., cardiac pacing parameters), and/or electrode vectors.Processing circuitry 220 may store such parameters and/or electrodevectors in memory 130.

Therapy delivery circuitry 224 and sensing circuitry 222 areelectrically coupled to electrodes 232, which may correspond toelectrodes 86 and 88 (FIGS. 3 and 5A). Processing circuitry 220 isconfigured to control therapy delivery circuitry 224 to generate anddeliver electrical therapy to heart 2 via electrodes 132. Electricaltherapy may include, for example, pacing pulses, or any other suitableelectrical stimulation. Processing circuitry 220 may control therapydelivery circuitry 224 to deliver electrical stimulation therapy viaelectrodes 232 according to one or more therapy parameter values, whichmay be stored in memory 230. Therapy delivery circuitry 224 may includecapacitors, current sources, and/or regulators, in some examples.

In addition, processing circuitry 220 is configured to control sensingcircuitry 222 to monitor signals from electrodes 232 in order to monitorelectrical activity of heart 2. Sensing circuitry 222 may includecircuits that acquire electrical signals, such as filters, amplifiers,and analog-to-digital circuitry. Electrical signals acquired by sensingcircuitry 222 may include intrinsic and/or paced cardiac electricalactivity, such as atrial depolarizations and/or ventriculardepolarizations. Sensing circuitry 222 may filter, amplify, and digitizethe acquired electrical signals to generate raw digital data. Processingcircuitry 220 may receive the digitized data generated by sensingcircuitry 222. In some examples, processing circuitry 120 may performvarious digital signal processing operations on the raw data, such asdigital filtering. In some examples, in addition to sensing circuitry222, IMD 10 optionally may include sensors 226, which may one or morepressure sensors and/or one or more accelerometers, as examples.Communication circuitry 228 may include any suitable hardware (e.g., anantenna), firmware, software, or any combination thereof forcommunicating with another device, e.g., external to the patient.

FIG. 8 is a flow diagram illustrating an example technique for usingtether assembly 12 of FIGS. 4A-5D and tether assembly 112 of FIGS.6A-6D. Although the example technique of FIG. 8 is described in thecontext of tether assembly 12 and tether head assembly 18 of FIGS.4A-5D, the example technique should not be understood to be so limited,but instead may be applied to a method of using tether assembly 112 andtether head assembly 118 of FIGS. 6A-6D or any other tether assemblyconfigured according to the techniques of this disclosure.

The example technique of FIG. 8 includes coupling tether head assembly18 of tether assembly 12 to attachment member 14 of IMD 10 (240). Forexample, a clinician may hold tether head assembly 18 in one hand andpress attachment member 14 into passageway 46 defined by outer member38, e.g., against distal end 65 of inner retainer 36, thereby movinginner retainer 36 to the second position as attachment member 14 movesthrough passageway 46 to receptacle 44 and as elastically-compressiblemember 60 is compressed. The clinician then may release his or her holdon IMD 10 once attachment member 14 is received within receptacle 44 toallow inner retainer 36 to return to the first position via the biasingof inner retainer 36 to the first position provided byelastically-compressible member 60.

The clinician then may position IMD 10 attached to tether head assembly18 at a treatment site of a patient (e.g., a treatment site within heart1) with attachment member 14 received within receptacle 44 (242). Insome examples, IMD 10 and tether assembly 12 may be carried within adelivery catheter 9 as it is advanced to the treatment site, e.g., asdescribed above with respect to FIGS. 2 and 3. In some examples, theclinician may determine whether IMD 10 is properly positioned relativeto heart 1 based on an impedance signal sensed via an electrical pathincluding IMD 10, attachment member 14, and one or more components oftether member 12 (e.g., inner retainer 36 and/or or one or more othercomponents of tether head assembly 18). The clinician then may advancefixation members 16 into the tissue of heart 1 to fix IMD 10 at theimplant site (244).

Once satisfied with the positioning and fixation of IMD 10 to tissue ofheart 1, the clinician may separate attachment member 14 of IMD 10 fromtether head assembly 18. For example, the clinician may proximally movepull wire 34, such as by applying force to an actuator of a tetherhandle assembly attached at a proximal end of pull wire 34, to moveinner retainer 36 from the first position to the second position (246).With inner retainer 36 in the second position, the clinician mayproximally move tether assembly 12 to remove attachment member 14 fromtether head assembly 18 (248). For example, proximal movement of tetherassembly 12 when inner retainer 36 is in the second position may enableattachment member 14 to pass from receptacle 44, through passageway 46,and out from distal end 48 of outer retainer 38.

FIGS. 9A-11J illustrate a proximal portion of another example tetherassembly 250 including a tether handle assembly 252. FIG. 9A is a planview of tether handle assembly 252, and FIG. 9B is an exploded plan viewof tether handle assembly 252. As illustrated in FIG. 9A, tether handleassembly 252 may be coupled to a proximal end of an elongate member 254of tether assembly 250, which may correspond with and be substantiallysimilar to elongate member 20 illustrated in FIGS. 3-6D. In someexamples, tether handle assembly 252 may be a handle assembly of atether assembly including either of tether head assemblies 18 or 118. Insome such examples, tether head assembly 18 or 118 may be coupled toelongate body 254 in a manner similar to a manner in which tether headassembly 18 or 118 may be coupled to elongate body 20 as describedabove. The tether head assemblies and tether handle assemblies describedherein may be used in any suitable combination with one another as partof a tether assembly. Thus, example combinations of the tether headassemblies and tether handle assemblies described are exemplary andshould not be understood to be limiting.

Tether handle assembly 252 includes a housing 258. A pull wire (notshown) may extend through elongate member 254, and may include aproximal end received within housing 258 of tether handle assembly 252.Tether handle assembly 252 further may include a button 260 defining aproximal surface 262. Button 260 may be configured to cause a proximalmovement of the pull wire when a distally-directed force is applied toproximal surface 262 of button 260. Proximal movement of the pull wiremay enable movement of an inner retainer 36 or 136 from a first positionto a second position, e.g., for removal of attachment member 14 of IMD10 from a tether head assembly 18 or 118, as described herein.

Housing 258 of tether handle assembly 252 may include a shroud 264 thatextends proximally of proximal surface 262 of button 260 such thatproximal surface 262 is recessed within housing 258. Shroud 264 thus mayhelp reduce a possibility of accidental application of adistally-directed force to proximal surface 262, which may help reduce apossibility of accidental deployment of IMD 10 during a procedure fordelivering IMD 10.

Tether handle assembly 252 further may include a strain relief member266 attached to housing 258 at a distal end 268 defined by housing 258.The pull wire of tether assembly 250 may extend through elongate member254 and be received within strain relief member 266. In addition toproviding strain relief for elongate member 254 and a pull wire wherethe pull wire enters distal end 268 of housing 258, strain relief member266 may help enable sensing of an impedance signal or enable electricaltesting of IMD 10 during a procedure to deliver IMD 10 at a treatmentsite.

In some examples, strain relief member 266 may be electricallyconductive, and electrically coupled to a conductive element of elongatebody 254. In such examples, strain relief member 266 may enable sensingof an impedance signal or other electrical signal via an electrical pathincluding IMD 10, attachment member 14, inner retainer 36 or 136, otherconductive components of tether head assembly 18 or 118, elongate member254, and strain relief member 266. For example, a clinician may couplean electrically conductive clip or similar connector from a deviceexternal to the patient during an implant procedure to strain reliefmember 266 to effectively electrically couple the external device tohousing 80 of IMD 10. A return electrode may be attached to patient andcoupled to the external device to provide the return path.

As discussed above with respect to FIG. 3, a clinician may determinewhether cup 8 and/or IMD 10 is properly positioned relative to tissue 15of heart 1, and/or whether IMD 10 is properly fixed to tissue byfixation members 16, based on an impedance signal sensed via such anelectrical path. In this manner, strain relief member 266 may helpenable a clinician to determine whether IMD 10 is properly placed at atreatment site.

As illustrated in FIG. 9B, the interior of housing 258 may define atleast a portion of a curved channel 270 that defines a first end 272 anda second end 274. In the illustrated example, an intermediate portion276 of curved channel 270 between first end 272 and second end 274 maybe separately formed and positioned within housing 258 during assemblyof handle assembly 252, e.g., for each of manufacturing of curvedchannel 270. Tether handle assembly 252 further may include a forcetransmitter 278 received within curved channel 270. In the illustratedexample, force transmitter 278 includes a plurality of balls (e.g.,ball-bearings) or other similar objects that are movable through channel270. However, other suitable objects configured to be received withinchannel 270 and movable therethrough may be used instead of or inaddition to the plurality of balls.

Tether handle assembly 252 further may include a slidable member 280received within housing 258 such that a channel portion 282 of slidablemember 280 is received within channel 270 at first end 272 of channel270. As illustrated in FIG. 9B, a proximal end 286 of pull wire 284 mayextend from elongate member 254, through strain relief member 266, andbe received within housing 258. Proximal end 286 of pull wire 284 isattached to slidable member 280. In the illustrated example, proximalend 286 of pull wire 284 is received within an anchor member 288, whichmay enable slidable member 280 to retain proximal end 286 of pull wire284, thereby attaching proximal end 286 of pull wire 284 to slidablemember 280.

Button 260 may include an elongate distal portion 290 received withinchannel 270 at second end 274. Distal portion 290 of button 260 may beconfigured to move force transmitter 278 within channel 270 toward firstend 272 and into contact with channel portion 282 of slidable member280. For example, when button 260 is moved from a first position to asecond position in response to application of a distally-directed forceto proximal surface 262 of button (e.g., by a clinician pressing thebutton), distal portion 290 of button 260 may contact force transmitter278 and move the force transmitter through channel 270 towards first end272. Since force transmitter 278 is in contact with portion 282 ofslidable member 280 received within channel 270, force transmitter 278applies a proximally-directed force to channel portion 282, and thus toslidable member 280. This proximally-directed force causes slidablemember 278 and pull wire 284 to move proximally. In this manner, channel270 and force transmitter 278 may be configured to translate adistally-directed force applied to proximal surface 262 of button 260 toa proximally-directed force applied to slidable member 280 and pull wire284. In some examples, a clinician may find applying a distally-directedforce (i.e., a pushing force) to button 260 to release IMD 10 to beintuitive and/or otherwise easier to use than some other handle assemblyconfigurations.

In some examples, tether handle assembly 252 may further include anelastically-compressible member 292, e.g., spring, positioned withinhousing 258 proximal to slidable member 280, which in some examples mayhelp control movement of slidable member 280. When handle assembly 252is in an assembled configuration, button 260 may surround at least aproximal portion of elastically-compressible member 292. Proximalmovement of slidable member 280 may axially compresseselastically-compressible member 292 relative to its longitudinal axis.In some examples, elastically-compressible member 292 may help controlproximal movement of slidable member 280 as slidable member 280 is movedproximally within housing 258. Additionally, or alternatively,elastically-compressible member 292 may be configured to bias slidablemember 280 and/or button 260 to respective first positions thereof,e.g., their positions when button 260 is not pushed distally inwardrelative to housing 258, as illustrated and described with respect toFIGS. 10A-10D. Thus, when a physician releases button 260, pull wire 284may be moved distally by elastically-compressible member 292 to aid inreturning a tether head assembly 18 or 118 to a closed configuration,e.g., returning an inner retainer 36 or 136 to the first position, insome examples. Some example tether assemblies may include both anelastically-compressible member in the handle assembly, e.g.,elastically compressible member 292, and an elastically-compressiblemember in the head assembly, e.g., elastically compressible member 60,while other tether assemblies may include only one of theelastically-compressible members to, for example, provide thefunctionality of returning a tether head assembly to a closedconfiguration, e.g., returning an inner retainer to the first position.

In some examples, as illustrated in FIG. 9B, housing 258 may comprise aremovable cover portion 296, which may facilitate manufacture of tetherhandle assembly 252. Tether handle assembly 252 further may include anelastically-stretchable band 294, which may be configured to be placedover a distal portions of housing 258 and cover 296 to help retaincomponents of handle assembly 252 in the assembled configurationillustrated in FIG. 9A.

FIGS. 10A-10D are side views of tether handle assembly 252 of FIGS. 9Aand 9B with a portion of housing 258 removed, illustrating movement offorce transmitter 278, slidable member 280, and a pull wire 284 inresponse to movement of button 260 from a first position 300 (FIG. 10A)to a second position 302 (FIG. 10D). First position 300 may be a “home”or uncompressed position of button 260. Second position 302 may be acompressed or depressed position of button 260. Elastically-compressiblemember 292 may bias button 260 to first position 300.

As shown in FIGS. 10B-10D, as button 260 is pushed inward into shroud264 with distal force in the direction of arrow 304, distal portion 290of button 260 moves distally in the direction of arrow 304 withinchannel 270. As distal portion 290 moves distally within channel 270,distal portion 290 pushes force transmitter 278 within channel towardfirst end 272 (FIG. 9B). In this manner, force transmitter 278 transmitsthe distally-directed force from button 260 to a proximally-directedforce, in the direction of arrow 306, against channel portion 282 ofslidable member 280. In response to the proximally-directed force,slidable member 280 and attached pull wire 284 may move proximally, inthe direction of arrow 306, which may result in opening of a tether headmember 18 or 118 at a distal end of a tether assembly, as describedherein.

As illustrated in FIG. 10B, housing 258 and button 260 may includefeatures configured to interact, e.g., abut, when button 260 is insecond position 302. Such features may prevent further distal movementof button 260 beyond second position 302. In the illustrated example,housing 258 defines an internal ledge 308 and button 260 includes adistal overhang 310.

As button 260 moves from first position 300 to second position 302 indistal direction 304, and slidable member 280 correspondingly moves inproximal direction 306, elastically-compressible member 292 iscompressed between button 260 and slidable member 280, storing potentialenergy. When a physician releases button 260, elastically-compressiblemember 292 may expand longitudinally, releasing the stored energy, andmoving button 260 and slidable member 280 in directions 306 and 304,respectively, until button 260 is once again in first position 300. Asslidable member 280 moves distally in direction 304, pull wire 284 mayalso move distally to aid in returning a tether head assembly 18 or 118in a closed configuration, e.g., returning an inner retainer 36 or 136to first position, in some examples.

FIGS. 11A-11J are plan views of components of tether handle assembly 252of tether assembly 250 of FIGS. 9A and 9B, illustrating an exampletechnique for assembling tether handle assembly 252. As illustrated inFIG. 11A pull wire 284 extends out of a proximal end of elongate member254, and through a strain relief member 266 at the proximal end ofelongate member 254. An anchor member 288 may be formed on or attachedto proximal end 286 of pull wire 284.

As illustrated in FIG. 11B, housing 258 may define a receptacle 320configured to receive strain relief member 266, and a channel 322configured to receive pull wire 284. Anchor member 288 may be positionedon an opposite end of channel 322 from strain relief member 266. Thisconfiguration, including the fixation of strain relief member 266 inreceptacle 320 of housing 258, may provide strain relief for theconnection of elongate member 254 to handle assembly 252.

FIG. 11C illustrates the insertion of intermediate portion 276 tocomplete curved channel 270, which also closes channel 322. FIG. 11Dillustrates slidable member 280 inserted into housing 258. Slidablemember 280 may define a feature (not shown) configured to receive anchormember 288, thereby coupling pull wire 284 to slidable member 280.

FIG. 11E illustrates elastically-compressible member 292 inserted intohousing 258, and FIG. 11F illustrates button 260 inserted into housing258. Slidable member 280 and button 260 may include features to holdelastically-compressible member 292 between them. FIG. 11F alsoillustrates distal portion 290 of button 260 inserted at second end 274of channel 270.

FIG. 11G illustrates force transmitter 278 inserted into channel 270between distal portion 290 of button 260 and channel portion 282 ofslidable member 280. FIG. 11H illustrates removable cover 296 attachedto housing 258, and FIG. 11I illustrates elastically-stretchable band294 placed over a distal portions of housing 258 and cover 296 to helpretain components of tether handle assembly 252 in the assembledconfiguration. FIGS. 11I and 11J also illustrate that housing 258 maydefine features to aid the usability of handle assembly 252, such asdepression 324 and ridge 326, which may aid a physician in orienting andgripping tether handle assembly 252.

FIGS. 12A-12E are plan views of another example tether handle assembly352. Tether handle assembly 352 may be substantially similar to tetherhandle assembly 252 described with reference to FIGS. 9A-11J. Forexample, components of tether handle assembly 352 having the samereference numbers as components tether handle assembly 252 may beconfigured and function as described with respect to FIGS. 9A-11J.

Unlike tether handle assembly 252, tether handle assembly 352 includes acover 354 for button 260 (FIG. 12E). Housing 358 of tether handleassembly 352, e.g., shroud portion 364 of the housing, may define adepression 370 configured to allow a user's finger to access a tab 372formed on cover 354 to move cover 354 away from button 260. Cover 354may be included on tether handle assembly 352 to reduce the likelihoodthat button 260 is inadvertently pressed, and IMD 10 deployed, during animplantation procedure for IMD 10 using tether handle assembly 352.

A band 376 may connect cover 354 to a collar 374. Collar 374 and band376 may be configured to keep cover 354 attached to tether handleassembly 352 when cover 354 is moved away from button 260, e.g., asshown in FIG. 12D. Band 376 may be configured to space cover 354 fromaway from a proximal opening of shroud portion 364 to facilitate ease ofuser access to proximal surface 262 of button 260 when cover 354 ismoved, e.g., as shown in FIGS. 12D and 12E. Cover 354, collar 374, andband 376 may be formed of any material, such as a polymer, and may beformed from, e.g., molded as, a single piece of the material. Shroudportion 364 and/or other portions of housing 358 may be configured withcorresponding features to receive collar 374 and band 376, e.g., tosecure them to tether handle assembly 352 and provide a substantiallyeven outer surface for tether handle assembly 352.

As illustrated in FIGS. 12D and 12E, cover 354 may include a reduceddiameter plug portion 378. As illustrated in FIG. 12E, the proximalopening of shroud portion 364 may define an expanded diameter shelf 380configured to receive plug portion 378. Plug portion 378 and shelf 380may be configured to interact secure cover 354 within the proximalopening of shroud portion 364, e.g., via friction fit, threading, orother attachment mechanisms.

FIGS. 13A and 13B are plan views of a proximal end of another exampletether assembly 412 including another example tether handle assembly 452coupled to a proximal end of an elongate member 454. FIG. 13C is anexploded plan view of tether handle assembly 452. FIGS. 13D and 13E areplan views of tether handle assembly 452, with a portion of a housing458 of tether handle assembly 452 removed to illustrate an example,arrangement, interaction, and movement of components of tether handleassembly 452 during use.

Elongate member 454 of tether assembly 412 may correspond with and besubstantially similar to elongate member 20 illustrated in FIGS. 3-6D.In some examples, tether handle assembly 452 may be a handle assembly oftether assembly including either of tether head assemblies 18 or 118. Insome such examples, tether head assembly 18 or 118 may be coupled toelongate body 454 in a manner similar to a manner in which tether headassembly 18 or 118 may be coupled to elongate body 20 as describedabove. The tether head assemblies and tether handle assemblies describedherein may be used in any suitable combination with one another as partof a tether assembly. Thus, example combinations of the tether headassemblies and tether handle assemblies described are exemplary andshould not be understood to be limiting.

In the example illustrated by FIG. 13C, housing 458 includes two housingportions 458A and 458B. Housing portions 458A and 458B may be press fittogether or otherwise connected during assembly of tether handleassembly 452 to form housing 458, e.g., after the components of tetherhandle assembly 452 described herein are suitably arranged. Housingportions 458A and 458B may be molded components of plastic or anotherpolymer in some examples.

A pull wire 484 (FIG. 13C) may extend through elongate member 454, andmay include a proximal end 486 received within housing 458 of tetherhandle assembly 452. Tether handle assembly 452 further may include abutton 460 defining a proximal surface 462, and configured to cause aproximal movement of pull wire 484 when a distally-directed force isapplied to the proximal surface 462 of button 460. Proximal movement ofthe pull wire 484 may enable movement of an inner retainer 36 or 136from a first position to a second position, e.g., for removal ofattachment member 14 of IMD 10 from a tether head assembly 18 or 118, asdescribed herein with respect to FIGS. 4A-6D.

Tether handle assembly 452 further may include a strain relief member466 attached to housing 458 at a distal end of housing 458. Elongatemember 454 may be attached to strain relief member 466 and pull wire 484may be received within strain relief member 466. In addition toproviding strain relief for elongate member 454 and pull wire 484 wherethe elongate member attaches to and the pull wire enters housing 458,strain relief member 466 may be electrically conductive and help enablesensing of an impedance signal or enable electrical testing of IMD 10during a procedure to deliver IMD 10 at a treatment site, as describedabove with respect to strain relief member 266.

As illustrated in FIG. 13C, button 460 includes a carriage 470 withinhousing defining interior teeth 472 configured to interact withcorresponding teeth of gears 474A and 474B (collectively, “gears 474”).Button 460 may be a machined and/or molded. Tether handle assembly 452further includes a slidable member 480 comprising teeth 482 on opposingsides of the slidable member. Teeth 482 of slidable member 480 areconfigured to interact with the teeth of gears 474. Slidable member 480defines a longitudinal lumen through which distal end 486 of pull wire484 extends, and into which a distal portion of a sleeve 488 may beinserted. Sleeve 488 may serve to attach pull wire 484 to slidablemember 480 by defining a lumen to receive proximal end 486 of pull wire484. Proximal end 486 of pull wire 484 may be fixed to sleeve 488 bywelding, crimping, capping, adhesive, and/or using an anchor member(e.g., anchor member 288 of FIG. 7B) as examples.

Tether handle assembly 452 further includes elastically-compressiblemembers 492A, 492B, and 492C (collectively, “elastically-compressiblemembers 492”), e.g., springs, within housing 458. The longitudinal lumendefined by slidable member 480 receives elastically-compressible member492C, which dampens the proximal motion of pull wired 484 as button 460is pushed distally.

FIGS. 13D and 13E are side views of tether handle assembly 452 withhousing portion 458A removed, illustrating movement of carriage 470,gears 474, slidable member 480, and pull wire 484 in response tomovement of button 460 from a first position (FIG. 13D) to a secondposition (FIG. 13E). The first position illustrated in FIG. 13D may be a“home” or uncompressed position of button 460. The second positionillustrated in FIG. 13E may be a compressed or depressed position ofbutton 460. Elastically-compressible members 492A and 492B may biasbutton 460 to the first position.

As shown in FIGS. 13D and 13E, as button 460 is pushed inward withdistal force in the direction of arrow 494, carriage 470 moves distallyin the direction of arrow 494 within housing 458. As carriage 470 movesdistally, teeth 472 rotate gears 474. As gears 474 rotate against teeth482 of slidable member 480, slidable member 480 is moved proximally inthe direction of arrow 496, and pull wire 484 connected to slidablemember 480 is pulled proximally in the direction of arrow 496. In thismanner, gears 474 transfer the distally-directed force from button 460to a proximally-directed force, in the direction of arrow 496, inresponse to which pull wire 484 may move proximally, in the direction ofarrow 496, which may result in opening of a tether head member 18 or 118at a distal end of tether assembly 412, in the manner described herein.

As button 460 moves from the first position (FIG. 13D) to the secondposition (FIG. 13E) in distal direction 494, elastically-compressiblemembers 492A and 492B are compressed between button 460 and features ofhousing 458, storing potential energy. When a physician releases button460, elastically-compressible members 492A and 492B may expandlongitudinally, releasing the stored energy, and moving button 460 andslidable member 480 in directions 496 and 494, respectively, untilbutton 460 is once again in the first position. As slidable member 480moves distally in direction 494, pull wire 484 may also move distally toaid in returning a tether head assembly 18 or 118 in a closedconfiguration, e.g., returning an inner retainer 36 or 136 to firstposition, in some examples.

FIG. 14 is a flow diagram illustrating an example technique for using atether assembly including a tether handle assembly as described withrespect to FIGS. 9A-13E and a tether head assembly as described withrespect to FIGS. 4A-6D. Although the example technique of FIG. 14 isdescribed in the context tether head assembly 18 of FIGS. 4A-5D andtether handle assembly 252 of FIGS. 9A-11J, the example technique shouldnot be understood to be so limited, but instead may be applied to amethod of using tether head assembly 118 of FIGS. 6A-6D, handleassemblies 352 and 452 of FIGS. 12A-12E, or any other tether headassemblies or tether handle assemblies configured according to thetechniques of this disclosure.

Like the example technique of FIG. 8, the example technique of FIG. 14includes positioning IMD 10 attached to tether head assembly 18 at atreatment site of a patient (e.g., a treatment site within heart 1) withattachment member 14 received within receptacle 44 (242). In someexamples, the clinician may determine whether IMD 10 is properlypositioned relative to heart 1 based on an impedance signal sensed viaan electrical path including IMD 10, attachment member 14, one or morecomponents of tether head assembly 18, an elongate member, and strainrelief member 266. The clinician then may advance fixation members 16into the tissue of heart 1 to fix IMD 10 at the implant site (244).

Once satisfied with the positioning and fixation of IMD 10 to tissue ofheart 1, the clinician may separate attachment member 14 of IMD 10 fromtether head assembly 18. In the example of FIG. 14, the clinician pushesdistally on proximal surface 262 of button 260 of tether handle assembly252 (500). Tether handle assembly 252 translates the distal force to aproximal force, to proximally move pull wire 282 and open tether headassembly 18 (502). For example, distal portion 290 of handle 260 maymove distally in channel 270 and push force transmitter 278 throughchannel 270 against channel portion 282 of slidable member 280, whichmay move slidable member 280 in a proximal direction. Pull wire 284,connected to slidable member 280, is thus moved in the proximaldirection.

In other examples, distal movement of carriage 470 of button 460 rotatesgears 474. The rotation of gears 474 moves slidable member 480, to whichpull wire 484 is connected, proximally. In either case, with tether headassembly 18 open, the clinician may proximally move tether assembly 12to remove attachment member 14 from tether head assembly 18 (248).

FIG. 15A is a side view of another example tether assembly 550 includinganother example tether handle assembly 552. FIG. 15B is an exploded planview of tether assembly 550 and tether handle assembly 552. FIGS.15C-15E are perspective views of tether handle assembly 552 with aportion 596 of the housing 558 removed, illustrating different positionsof a lock member 570 and a plunger 560 of tether handle assembly 552during use.

As illustrated in FIG. 15A, tether handle assembly 552 may be coupled toa proximal end of an elongate member 554 of tether assembly 550, whichmay correspond with and be substantially similar to elongate member 20illustrated in FIGS. 3-6D. In some examples, tether handle assembly 552may be a tether handle assembly of a tether assembly including either oftether head assemblies 18 or 118. In some such examples, tether headassembly 18 or 118 may be coupled to elongate body 554 in a mannersimilar to a manner in which tether head assembly 18 or 118 may becoupled to elongate body 20 as described above. The tether headassemblies and tether handle assemblies described herein may be used inany suitable combination with one another as part of a tether assembly.Thus, example combinations of the tether head assemblies and tetherhandle assemblies described are exemplary and should not be understoodto be limiting.

Tether handle assembly 552 includes a housing 558. A pull wire 584 mayextend through elongate member 554, and may include a proximal endreceived within housing 558 of tether handle assembly 552. Tether handleassembly 552 further may include a plunger 560 configured to cause aproximal movement of the pull wire when pulled by a user. Proximalmovement of the pull wire may enable movement of an inner retainer 36 or136 from a first position to a second position, e.g., for removal ofattachment member 14 of IMD 10 from a tether head assembly 18 or 118, asdescribed with respect to FIGS. 4A-6D.

Tether handle assembly 552 further may include a strain relief member566 attached to housing 558 at a distal end of housing 558. Elongatemember 554 may be attached to strain relief member 566, and pull wire584 may be received within strain relief member 566. In addition toproviding strain relief for elongate member 554 and pull wire 584 wherethe elongate member attaches to and the pull wire enters housing 558,strain relief member 566 be electrically conductive and may help enablesensing of an impedance signal or enable electrical testing of IMD 10during a procedure to deliver IMD 10 at a treatment site, as describedherein with respect to strain relief member 266.

In the illustrated example, housing 558 includes removable cover portion596, which may facilitate manufacture of handle assembly 552. Handleassembly 552 further may include an elastically-stretchable band 594,which may be configured to be placed over a distal portions of housing558 and cover 596 to help retain components of tether handle assembly552 in the assembled configuration illustrated in FIG. 15A.

As illustrated in FIG. 15B, tether handle assembly 552 includes a lockmember 570. Lock member 570 include opposing buttons 572A and 572B(collectively, “buttons 572”). Lock member 570 also defines a keyhole574. Tether handle assembly 552 further comprises a slidable member 576comprising a protrusion 578. Slidable member 576 is slidable through aninner channel defined by lock member 570 so long as protrusion 578 isaligned with keyhole 574 defined by lock member 570. As illustrated inFIG. 15B, a proximal end 586 of pull wire 584 may extend from elongatemember 554, through strain relief member 566, and be received withinhousing 558. Proximal end 586 of pull wire 584 is attached to slidablemember 576. In the illustrated example, proximal end 586 of pull wire584 is received within an anchor member 588, which may enable slidablemember 576 to retain proximal end 586, thereby attaching pull wire 584to slidable member 576.

Plunger 560 may include a plug 562 received within a collar 564. Collar564 defines an interior passageway configured to receive a proximalportion of slidable member 576, including bayonet locks 580. Plug 562 isinsertable into the interior passageway of collar 564 between bayonetlocks 580, to urge the bayonet locks outward and attach plunger 560 toslidable member 576.

In some examples, tether handle assembly 552 may further include anelastically-compressible member 592, e.g., spring, positioned between aninterior surface of housing 558 on one end, and an enlarged diameterportion 582 of slidable member 576 on the opposite end. Proximalmovement of slidable member 576 may axially compresseselastically-compressible member 592 relative to its longitudinal axis.In some examples, elastically-compressible member 592 may help controlproximal movement of slidable member 576 as slidable member 576 is movedproximally in response to a user pulling plunger 560. Additionally, oralternatively, elastically-compressible member 592 may be configured tobias slidable member 576 and/or plunger 560 to respective firstpositions thereof, e.g., their positions when plunger 560 has not beenpulled. Thus, when a physician releases plunger 560, pull wire 584 maybe moved distally by elastically-compressible member 592 to aid inreturning a tether head assembly 18 or 118 in a closed configuration,e.g., returning an inner retainer 36 or 136 to first position, in someexamples.

FIGS. 15C-15E are perspective views of tether handle assembly 552 with aportion 596 of the housing 558 removed, illustrating different positionsof a lock member 570 and a plunger 560 of tether handle assembly 552during use. FIG. 15C illustrates both lock member 570 and plunger 560 intheir first or “home” positions. In the first position, protrusion 578of slidable member 576 is not aligned with keyhole 574 of lock member570. Consequently, plunger 560 is prevented from being pulled distallyto its second position.

FIG. 15D illustrates lock member 570 in its second position, such thatprotrusion 578 of slidable member 576 is not aligned with keyhole 574 oflock member 570. A user may move lock member 570 to the second positionby pressing on button 572A of lock member 570 to move lock member 570transverse to a longitudinal axis of tether handle assembly 552. A usermay move lock member 570 back to the first position by pressing onbutton 572B, e.g., after deploying IMD 10. Notably, it is easier for auser to access button 572B than button 572A in both the first and secondpositions of lock member 570, e.g., to discourage accidental unlockingand IMD deployment.

FIG. 15E illustrates lock member 570 in its second position and plunger560 having been pulled to its second position. Pulling plunger 560 toits second position moves pull wire 584 proximally and compresseselastically-compressible member 592, storing potential energy. When aphysician releases plunger 560, elastically-compressible member 592 mayexpand longitudinally, releasing the stored energy, and moving plunger560 and slidable member 576 distally. As slidable member 576 movesdistally, pull wire 584 may also move distally to aid in returning atether head assembly 18 or 118 in a closed configuration, e.g.,returning an inner retainer 36 or 136 to first position, in someexamples.

FIG. 16A is an exploded plan view of another example tether handleassembly 652. FIG. 14B is a cross-section view of tether handle assembly652. Except as noted herein, tether handle assembly 652 may besubstantially similar to tether handle assembly 552 described above withrespect to FIGS. 15A-15E. For example, components of tether handleassembly 652 having the same reference numbers as components in tetherhandle assembly 552 may be configured and function as described withrespect to FIGS. 15A-15E.

Plunger 660 differs from plunger 560 in that collar 664 defines anaperture 665. Removable housing portion 696 and slidable member 676 alsodefine apertures 697 and 678, respectively. Apertures 697, 665, and 678align to define a passageway to receive a lower portion of a lock member670 of tether handle assembly 652 within housing 558. Lock member 670includes a lower post 674 receivable within a longitudinal lumen definedby elastically-compressible member 675, which biases lock member 670 toa locked position. Lock member 670 further defines an inlet 672 thatacts as a keyhole for lock member 670. When lock member 670 is presseddown and into the unlocked position, compressingelastically-compressible member 675, inlet 672 aligns with a distal edge667 of aperture 665 defined by collar 664. The alignment of inlet 672and distal edge 667 allows plunger 660 to be pulled proximally. FIG. 16Billustrates lock member 670 in the unlocked position, with inlet 672 anddistal edge 667 not aligned, and plunger 670 prevented from being pulledproximally, e.g., to open a tether head member and release an IMD.

FIG. 17A is an exploded plan view of another example tether handleassembly 752. FIG. 17B is a cross-section view of tether handle assembly752. FIG. 17C is a plan view of a collar portion 764 of a plunger 760 oftether handle assembly 752. Except as noted herein, tether handleassembly 752 may be substantially similar to tether handle assembly 552described above with respect to FIGS. 15A-15E. For example, componentsof tether handle assembly 752 having the same reference numbers ascomponents in tether handle assembly 552 may be configured and functionas described with respect to FIGS. 15A-15E.

Plunger 760 differs from plunger 560 in that collar 764 includes acantilevered lock mechanism 770. Additionally, housing 758 defines anaperture 759 configured to receive a button portion 774 of lockmechanism 770 when in the locked position. Button portion 774 is coupledto collar 764 by an arm portion 772, which biases button portion 774into the locked position, as illustrated in FIG. 17B. When buttonportion 774 is received in aperture 759 of housing 758, a user isprevented from proximally pulling plunger 760 and releasing IMD 10. Theuser may press button portion 774 into housing 758, unlockingcantilevered lock mechanism 770, and allowing the user to pull plunger760 proximally (thus pulling pull wire 784) and release IMD 10.

The following examples are illustrative of the techniques describedherein.

Example 1: A tether assembly of a medical device delivery system, thetether assembly comprising: a pull wire defining a proximal end and adistal end; and a tether head assembly. The tether head assemblycomprises: an inner retainer comprising a proximal portion and a distalportion, wherein the inner retainer is coupled to and extends distallyfrom the distal end of the pull wire; an outer retainer comprising aproximal portion defining a channel configured to receive the innerretainer and a distal portion defining an aperture. The aperturecomprises: a receptacle configured to receive an attachment member of amedical device; a passageway extending from a distal end defined by theouter retainer proximally to the receptacle, wherein the passageway isnarrower than the receptacle; and a groove extending from the distal endof the outer retainer proximally at least to the receptacle, wherein thegroove has a depth that is less than a thickness of the distal portionof the inner retainer, wherein the inner retainer is movable between afirst position wherein the distal portion of the inner retainer ispartially received in the groove and extends into the passageway,thereby narrowing the passageway, and a second position wherein thedistal portion of the inner retainer is positioned proximal to thepassageway.

Example 2: The tether assembly of example 1, wherein the passageway isdimensioned to receive the attachment member of the medical device whenthe inner retainer is in the second position, and wherein the passagewayis dimensioned to prevent passage of the attachment member when theinner retainer is in the first position.

Example 3: The tether assembly of example 2, wherein the passageway isdimensioned to retain the attachment member of the medical device withinthe receptacle when attachment member is received within the receptacleand the inner retainer is in the first position.

Example 4: The tether assembly of any of examples 1 to 3, wherein thedistal portion of the inner retainer comprises: a first portionincluding a distal end of the inner retainer, the first portion having afirst thickness; a second portion proximal to the first portion, thesecond portion having a second thickness that is greater than the firstthickness; and a third portion extending between the first portion andthe second portion, the third portion tapering in thickness from thefirst thickness to the second thickness.

Example 5: The tether assembly of example 4, wherein at least the thirdportion of the inner retainer is configured to contact the attachmentmember of the medical device when the inner retainer is in the firstposition.

Example 6: The tether assembly of any of examples 1 to 5, wherein theinner retainer and the attachment member of the medical device areelectrically conductive.

Example 7: The tether assembly of any of examples 1 to 6, wherein theinner retainer is configured to move from the first position to thesecond position in response to proximal movement of the pull wirerelative to the outer retainer.

Example 8: The tether assembly of any of examples 1 to 7, wherein theinner retainer is configured to move from the first position to thesecond position in response to an application of force to the innerretainer by the attachment member of the medical device.

Example 9: The tether assembly of example 8, further comprising a tetherhandle assembly attached to the proximal end of the pull wire, whereinthe tether handle assembly comprises an actuator configured to cause theproximal movement of the pull wire.

Example 10: The tether assembly of example 9, wherein the tether handleassembly is configured such that the pull wire moves proximally inresponse to a distally-directed force applied to the actuator and movesdistally in response to removal of the distally-directed force from theactuator.

Example 11: The tether assembly of any of examples 8 to 10, furthercomprising an elongate body defining a proximal end, a distal end, and alumen, wherein a first portion of the pull wire is received within theelongate body.

Example 12: The tether assembly of example 11, wherein the tether headassembly further comprises an elastically-compressible member defining alumen, wherein a second portion of the pull wire is received within thelumen defined by the elastically-compressible member such that theelastically-compressible member is positioned proximal to the innerretainer.

Example 13: The tether assembly of example 12, wherein theelastically-compressible member defines a longitudinal axis, and whereinthe inner retainer is configured move from the second position to thefirst position in response to axial expansion of theelastically-compressible member relative to the longitudinal axis.

Example 14: The tether assembly of example 12 or 13, wherein the tetherhead assembly further comprises a sheath attached to the distal end ofthe elongate body, wherein the elastically-compressible member, theproximal portion of the inner retainer, and the proximal portion of theouter retainer are received within the sheath.

Example 15: The tether assembly of any of examples 12 to 14, wherein theelastically-compressible member is configured to apply adistally-directed force to the inner retainer that biases the innerretainer to the first position.

Example 16: The tether assembly of any of examples 12 to 15, wherein theelastically-compressible member comprises a polymer material.

Example 17: The tether assembly of example 16, wherein the tether handleassembly is attached to the proximal end of the pull wire at theproximal end of the elongate body, and wherein the tether handleassembly is configured to cause the proximal movement of the pull wireby translating a distally-directed force applied by a user to theactuator into the proximal movement of the pull wire.

Example 18: A method for using a tether assembly of a medical devicedelivery system, the method comprising: positioning a tether headassembly of the tether assembly at a treatment site of a patient with anattachment member of a medical device received within a receptacle ofthe tether head assembly, the tether head assembly configured toreleasably retain the attachment member of the medical device. Thetether head assembly comprises: an inner retainer comprising a proximalportion and a distal portion, wherein the inner retainer is coupled toand extends distally from the distal end of a pull wire of the tetherassembly; an outer retainer comprising a proximal portion defining achannel configured to receive the inner retainer and a distal portiondefining an aperture. The aperture comprise the receptacle configured toreceive the attachment member of the medical device; a passagewayextending from a distal end of the outer retainer proximally to thereceptacle, wherein the passageway is narrower than the receptacle; anda groove extending from the distal end of the outer retainer proximallyat least to the receptacle, wherein the groove has a depth that is lessthan a thickness of the distal portion of the inner retainer.Positioning the tether head assembly comprises positioning the tetherhead assembly with the inner retainer in a first position wherein thedistal portion of the inner retainer is partially received in the grooveand extends into the passageway, thereby narrowing the passageway,wherein the passageway is dimensioned to prevent passage of theattachment member when the inner retainer is in the first position. Themethod further comprises applying a force to an actuator of tetherassembly to cause a proximal movement of the pull wire, the proximalmovement of the pull wire moving the inner retainer from the firstposition to a second position wherein the distal portion of the innerretainer is positioned proximal to the passageway, wherein thepassageway is dimensioned to receive the attachment member of themedical device when the inner retainer is in the second position,allowing the attachment member of the medical device to pass from thereceptacle through the passageway; and proximally moving the tetherassembly with the inner retainer in the second position to remove theattachment member of the medical device from the tether head assembly,thereby delivering the medical device to the treatment site.

Example 19: The method of example 18, further comprising, prior topositioning the tether head assembly, pressing the attachment member ofthe medical device against a distal end of the inner retainer to movethe inner retainer from the first position to the second position,allowing passage of the attachment member of the medical device throughthe passageway and into the receptacle defined by the outer retainer.

Example 20: The method of example 18 or 19, wherein the inner retainerand the attachment member of the medical device are electricallyconductive, the method further comprising: determining whether to applythe force to the actuator based on an impedance signal sensed via anelectrical path including the medical device, the attachment member, andthe inner retainer.

Example 21: The method of any of examples 18 to 20, wherein a tetherhandle assembly of the tether assembly comprises a housing defining aproximal end and a distal end, wherein the actuator comprises a buttondefining a proximal surface that is distal to the proximal end of thehousing when the button is in the first position, and wherein theapplying the force to the actuator comprises applying adistally-directed force to the proximal surface.

Example 22: The method of any of examples 18 to 20, wherein a tetherhandle assembly of the tether assembly comprises a lock member, and themethod further comprises moving the lock member from a first positionwherein the lock member restricts actuation of the actuator to a secondposition wherein the lock member does not restrict actuation of theactuator.

Various aspects of the disclosure have been described. These and otheraspects are within the scope of the following claims.

What is claimed is:
 1. A tether assembly of a medical device deliverysystem, the tether assembly comprising: a tether head assemblycomprising: an inner retainer; an outer retainer comprising a proximalportion defining a channel configured to receive the inner retainer anda distal portion defining an aperture, the aperture comprising: areceptacle configured to receive an attachment member of a medicaldevice; a passageway extending from a distal end defined by the outerretainer proximally to the receptacle; and a groove extending from thedistal end of the outer retainer proximally at least to the receptacle,wherein the inner retainer is movable between a first position whereinthe distal portion of the inner retainer is partially received in thegroove and extends into the passageway, thereby narrowing thepassageway, and a second position wherein the distal portion of theinner retainer is positioned proximal to the passageway.
 2. The tetherassembly of claim 1, wherein the passageway is dimensioned to receivethe attachment member of the medical device when the inner retainer isin the second position, and wherein the passageway is dimensioned toprevent passage of the attachment member when the inner retainer is inthe first position.
 3. The tether assembly of claim 1, wherein thepassageway is dimensioned to retain the attachment member of the medicaldevice within the receptacle when attachment member is received withinthe receptacle and the inner retainer is in the first position.
 4. Thetether assembly of claim 1, wherein the passageway is narrower than thereceptable.
 5. The tether assembly of claim 1, wherein the groove has adepth less than a thickness of a distal portion of the inner retainer.6. The tether assembly of claim 1, wherein a distal portion of the innerretainer comprises: a first portion including a distal end of the innerretainer, the first portion having a first thickness; a second portionproximal to the first portion, the second portion having a secondthickness that is greater than the first thickness; and a third portionextending between the first portion and the second portion, the thirdportion tapering in thickness from the first thickness to the secondthickness.
 7. The tether assembly of claim 1, wherein the inner retainerand the attachment member of the medical device are electricallyconductive.
 8. The tether assembly of claim 1, wherein the innerretainer is configured to move from the first position to the secondposition in response to an application of force to the inner retainer bythe attachment member of the medical device.
 9. The tether assembly ofclaim 1, further comprising a pull wire defining a proximal end and adistal end, wherein the inner retainer is coupled to and extendsdistally from the distal end of the pull wire.
 10. The tether assemblyof claim 9, wherein the inner retainer is configured to move from thefirst position to the second position in response to proximal movementof the pull wire relative to the outer retainer.
 11. The tether assemblyof claim 9, further comprising a tether handle assembly attached to theproximal end of the pull wire, wherein the tether handle assemblycomprises an actuator configured to cause the proximal movement of thepull wire.
 12. The tether assembly of claim 11, wherein the tetherhandle assembly is configured such that the pull wire moves proximallyin response to a distally-directed force applied to the actuator andmoves distally in response to removal of the distally-directed forcefrom the actuator.
 13. The tether assembly of claim 9, furthercomprising an elongate body defining a proximal end, a distal end, and alumen, wherein a first portion of the pull wire is received within theelongate body.
 14. The tether assembly of claim 9, wherein the tetherhead assembly further comprises an elastically-compressible memberdefining a lumen, wherein a second portion of the pull wire is receivedwithin the lumen defined by the elastically-compressible member suchthat the elastically-compressible member is positioned proximal to theinner retainer.
 15. The tether assembly of claim 14, wherein theelastically-compressible member is configured to apply adistally-directed force to the inner retainer that biases the innerretainer to the first position.
 16. The tether assembly of claim 14,wherein the elastically-compressible member comprises a polymermaterial.
 17. The tether assembly of claim 1, wherein the tether headassembly further comprises a sheath, wherein the inner retainer and theouter retainer are received within the sheath.
 18. A method for using atether assembly of a medical device delivery system, the methodcomprising: positioning a tether head assembly of the tether assembly ata treatment site of a patient with an attachment member of a medicaldevice received within a receptacle of the tether head assembly, thetether head assembly configured to releasably retain the attachmentmember of the medical device, wherein the tether head assemblycomprises: an inner retainer; an outer retainer comprising a proximalportion defining a channel configured to receive the inner retainer anda distal portion defining an aperture, the aperture comprising: thereceptacle configured to receive the attachment member of the medicaldevice; a passageway extending from a distal end of the outer retainerproximally to the receptacle; and a groove extending from the distal endof the outer retainer proximally at least to the receptacle, whereinpositioning the tether head assembly comprises positioning the tetherhead assembly with the inner retainer in a first position wherein thedistal portion of the inner retainer is partially received in the grooveand extends into the passageway, thereby narrowing the passageway,wherein the passageway is dimensioned to prevent passage of theattachment member when the inner retainer is in the first position;moving the inner retainer from the first position to a second positionwherein the distal portion of the inner retainer is positioned proximalto the passageway and allows the attachment member of the medical deviceto pass from the receptacle through the passageway; and removing theattachment member of the medical device from the tether head assembly.19. The method of claim 18, further comprising, prior to positioning thetether head assembly, pressing the attachment member of the medicaldevice against a distal end of the inner retainer to move the innerretainer from the first position to the second position.
 20. The methodof claim 18, further comprising: determining whether to apply the forceto the actuator based on an impedance signal sensed via an electricalpath including the medical device, the attachment member, and the innerretainer.